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Tixagevimab
Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two monoclonal antibody, human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational Pharmaceutical industry, pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession). Development In 2020, researchers at Vanderbilt University Medical Center discovered particularly potent monoclonal antibodies, isolated from COVID-19 patients infected with a SARS-CoV-2 circulating at that time. Initially designated COV2-2196 and COV2-2130, antibody engineering was used to transfer their SARS-CoV-2 binding specificity to IgG scaffolds that would last longer in the body, and these engineered antibodies were named AZ ...
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Tixagevimab
Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two monoclonal antibody, human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational Pharmaceutical industry, pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession). Development In 2020, researchers at Vanderbilt University Medical Center discovered particularly potent monoclonal antibodies, isolated from COVID-19 patients infected with a SARS-CoV-2 circulating at that time. Initially designated COV2-2196 and COV2-2130, antibody engineering was used to transfer their SARS-CoV-2 binding specificity to IgG scaffolds that would last longer in the body, and these engineered antibodies were named AZ ...
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Cilgavimab
Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession). Development In 2020, researchers at Vanderbilt University Medical Center discovered particularly potent monoclonal antibodies, isolated from COVID-19 patients infected with a SARS-CoV-2 circulating at that time. Initially designated COV2-2196 and COV2-2130, antibody engineering was used to transfer their SARS-CoV-2 binding specificity to IgG scaffolds that would last longer in the body, and these engineered antibodies were named AZD8895 (tixagevimab) and AZD1061 (cilgav ...
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Coronavirus Spike Protein
Spike (S) glycoprotein (sometimes also called spike protein, formerly known as E2) is the largest of the four major structural proteins found in coronaviruses. The spike protein assembles into trimers that form large structures, called spikes or peplomers, that project from the surface of the virion. The distinctive appearance of these spikes when visualized using negative stain transmission electron microscopy, "recalling the solar corona", gives the virus family its name. The function of the spike glycoprotein is to mediate viral entry into the host cell by first interacting with molecules on the exterior cell surface and then fusing the viral and cellular membranes. Spike glycoprotein is a class I fusion protein that contains two regions, known as S1 and S2, responsible for these two functions. The S1 region contains the receptor-binding domain that binds to receptors on the cell surface. Coronaviruses use a very diverse range of receptors; SARS-CoV (which causes SARS) an ...
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Monoclonal Antibodies
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies can have monovalent affinity, binding only to the same epitope (the part of an antigen that is recognized by the antibody). In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different antibody-secreting plasma cell lineages. Bispecific monoclonal antibodies can also be engineered, by increasing the therapeutic targets of one monoclonal antibody to two epitopes. It is possible to produce monoclonal antibodies that specifically bind to virtually any suitable substance; they can then serve to detect or purify it. This capability has become an investigative tool in biochemistry, molecular biology, and medicine. Monoclonal antibodies are being used on a clinical level for both the diagnosis and therapy ...
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DailyMed
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this information from the pharmaceutical industry. The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference Information Model (RIM). , it contained information about 140,232 drug listings. It includes an RSS feed for updated drug information. History In 2006 the FDA revised the drug label and also created DailyMed to keep prescription information up to date. See also * Consum ...
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The Guardian
''The Guardian'' is a British daily newspaper. It was founded in 1821 as ''The Manchester Guardian'', and changed its name in 1959. Along with its sister papers ''The Observer'' and ''The Guardian Weekly'', ''The Guardian'' is part of the Guardian Media Group, owned by the Scott Trust. The trust was created in 1936 to "secure the financial and editorial independence of ''The Guardian'' in perpetuity and to safeguard the journalistic freedom and liberal values of ''The Guardian'' free from commercial or political interference". The trust was converted into a limited company in 2008, with a constitution written so as to maintain for ''The Guardian'' the same protections as were built into the structure of the Scott Trust by its creators. Profits are reinvested in journalism rather than distributed to owners or shareholders. It is considered a newspaper of record in the UK. The editor-in-chief Katharine Viner succeeded Alan Rusbridger in 2015. Since 2018, the paper's main news ...
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Reuters
Reuters ( ) is a news agency owned by Thomson Reuters Corporation. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide. Reuters is one of the largest news agencies in the world. The agency was established in London in 1851 by the German-born Paul Reuter. It was acquired by the Thomson Corporation of Canada in 2008 and now makes up the media division of Thomson Reuters. History 19th century Paul Reuter worked at a book-publishing firm in Berlin and was involved in distributing radical pamphlets at the beginning of the Revolutions in 1848. These publications brought much attention to Reuter, who in 1850 developed a prototype news service in Aachen using homing pigeons and electric telegraphy from 1851 on, in order to transmit messages between Brussels and Aachen, in what today is Aachen's Reuters House. Reuter moved to London in 1851 and established a news wire agency at the London Royal Exchange. Headquartered in London, Reuter' ...
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Bahrain
Bahrain ( ; ; ar, البحرين, al-Bahrayn, locally ), officially the Kingdom of Bahrain, ' is an island country in Western Asia. It is situated on the Persian Gulf, and comprises a small archipelago made up of 50 natural islands and an additional 33 artificial islands, centered on Bahrain Island which makes up around 83 percent of the country's landmass. Bahrain is situated between Qatar and the northeastern coast of Saudi Arabia, to which it is connected by the King Fahd Causeway. According to the 2020 census, the country's population numbers 1,501,635, of which 712,362 are Bahraini nationals. Bahrain spans some , and is the third-smallest nation in Asia after the Maldives and Singapore. The capital and largest city is Manama. Bahrain is the site of the ancient Dilmun civilization.Oman: The Lost Land
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Emergency Use Authorization
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by , to allow the use of a drug prior to approved drug, approval. It does not constitute ''approval'' of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security. Use EUAs have historically been infrequent. A review article by Rizk et al. provides a summary of the US experience in 2020 with pharmacological EUA approvals during the COVID-19 pandemic. It also provides a descripti ...
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Committee For Medicinal Products For Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use. See also * Committee for Medicinal Products for Veterinary Use The Committee for Medicinal Products for Veterinary Use (CVMP) is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding veterinary medicines. Text was copied from this source which is © ... References External links Committee for Medicinal Products for Human Use (CHMP) Health and the European Union {{eu-stub ...
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Clinical Endpoint
Clinical endpoints or clinical outcomes are Outcome measure, outcome measures referring to occurrence of disease, symptom, Medical sign, sign or laboratory abnormality constituting a target outcome in clinical trial, clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ''humane (clinical) endpoint''. The primary endpoint of a clinical trial is the endpoint for which the trial is statistical power, powered. Secondary endpoints are additional endpoints, preferably also pre-specified, for which the trial may not be powered. Surrogate endpoint, Surrogate endpoints are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is difficult, for example using an increase in blood pressure as a surrogate for death by cardiovascular disease, where strong evidence of a causal link exists. Scope In a general sens ...
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SARS-CoV-2 Omicron Variant
Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World Health Organization (WHO) by the Network for Genomics Surveillance in South Africa on 24 November 2021. It was first detected in Botswana and has spread to become the predominant variant in circulation around the world. Following the original BA.1 variant, several subvariants of Omicron have emerged: BA.2, BA.3, BA.4, and BA.5. Since October 2022, two subvariants of BA.5 named BQ.1 and BQ.1.1 have spread rapidly. Three doses of a COVID-19 vaccine provide protection against severe disease and hospitalisation caused by BA.1 and BA.2. The immunity effects of BA.2 are similar to those of BA.1. For three-dose vaccinated individuals, the BA.4 and BA.5 variants are more infectious than previous subvariants, making it likely, , for a new peak in COVID-19 infections to occur. __TOC__ Classification On 26 November, the WHO's Technical Advisory Group on SARS-CoV-2 Virus Evolution declared PANGO linea ...
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